search
Back to results

Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy (SNAP-PS)

Primary Purpose

Obesity, Morbid

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Self Forming Magnetic (SFM) Anastomosis System
Sponsored by
GI Windows, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity, Morbid

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 22-65 years at screening
  • Body mass index (BMI) ≥35 and ≤50
  • Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain.
  • Weight stable over 3-month period
  • Negative H. pylori breath test
  • Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years
  • If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period
  • Able to understand and sign informed consent documents.

Exclusion Criteria:

  • Known or suspected allergy to nickel or titanium or nitinol
  • Contraindication to general anesthesia
  • Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series
  • Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon.
  • Clinically significant findings during screening endoscopy at target region for compression anastomosis
  • Uncontrolled hypertension
  • Pre-existing severe comorbid cardio-respiratory disease
  • History of type 1 diabetes or poorly controlled type 2 diabetes
  • Abnormal liver biochemistry
  • History of chronic gastrointestinal disease
  • Specific genetic or hormonal cause of obesity
  • Recent tobacco/nicotine product cessation (within 3 months prior)

Sites / Locations

  • Centro Medico Teknon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SFM Treatment Arm

Arm Description

The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion

Outcomes

Primary Outcome Measures

Weight Loss
1. Weight loss measured as a percent of total body weight (TBW)

Secondary Outcome Measures

Percent responders
Percent of subjects losing at least 10% and 20% of baseline weight from baseline
Excess weight loss
Mean change in Excess weight loss from baseline
Change in serum lipids
Mean change in serum lipids from baseline
Change in blood pressure
Mean change in blood pressure from baseline
Change in fasting glucose
Mean change in fasting glucose in subjects with T2DM at baseline
Change in HbA1c
Mean change in HbA1c in subjects with T2DM at baseline
Change in BMI
Mean change in BMI from baseline
Change in Absolute Weight Loss
Mean change in Absolute Weight Loss from baseline

Full Information

First Posted
September 9, 2021
Last Updated
September 25, 2023
Sponsor
GI Windows, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT05049824
Brief Title
Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy
Acronym
SNAP-PS
Official Title
Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects With Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 26, 2021 (Actual)
Primary Completion Date
June 25, 2023 (Actual)
Study Completion Date
June 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GI Windows, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study will monitor weight loss and metabolic indicators for subjects in single-center, single arm trial.
Detailed Description
Single-Center, Open-label Pilot Study to Evaluate the Safety and Effectiveness of the GI Windows Single Neodymium Magnet Anastomosis Procedure When Used to Create a Duodenal-Ileal Diversion for Subjects with Inadequate Weight Loss or Weight Regain Following Sleeve Gastrectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SFM Treatment Arm
Arm Type
Experimental
Arm Description
The subjects in this arm will receive the Self-Forming Magnet (SFM) System that will be used to create a duodenal-ileal diversion
Intervention Type
Device
Intervention Name(s)
Self Forming Magnetic (SFM) Anastomosis System
Intervention Description
The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators
Primary Outcome Measure Information:
Title
Weight Loss
Description
1. Weight loss measured as a percent of total body weight (TBW)
Time Frame
12 Months
Secondary Outcome Measure Information:
Title
Percent responders
Description
Percent of subjects losing at least 10% and 20% of baseline weight from baseline
Time Frame
12 Months
Title
Excess weight loss
Description
Mean change in Excess weight loss from baseline
Time Frame
12 Months
Title
Change in serum lipids
Description
Mean change in serum lipids from baseline
Time Frame
12 Months
Title
Change in blood pressure
Description
Mean change in blood pressure from baseline
Time Frame
12 Months
Title
Change in fasting glucose
Description
Mean change in fasting glucose in subjects with T2DM at baseline
Time Frame
12 Months
Title
Change in HbA1c
Description
Mean change in HbA1c in subjects with T2DM at baseline
Time Frame
12 Months
Title
Change in BMI
Description
Mean change in BMI from baseline
Time Frame
12 Months
Title
Change in Absolute Weight Loss
Description
Mean change in Absolute Weight Loss from baseline
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 22-65 years at screening Body mass index (BMI) ≥35 and ≤50 Patient is ≥12 months but ≤ 60 months post sleeve gastrectomy who have inadequate weight loss or weight regain. Weight stable over 3-month period Negative H. pylori breath test Agrees to refrain from any type of additional bariatric or reconstructive surgery that would affect body weight for a duration of 2 years If female, subject must commit to not becoming pregnant for 24 months and agree to use contraception during this period Able to understand and sign informed consent documents. Exclusion Criteria: Known or suspected allergy to nickel or titanium or nitinol Contraindication to general anesthesia Previous technical difficulty or failed endoscopy or contraindication to endoscopy of upper GI series Any previous major surgery on the stomach (excluding sleeve gastrectomy), duodenum, hepatobiliary tree (excluding gallbladder), pancreas, or right colon. Clinically significant findings during screening endoscopy at target region for compression anastomosis Uncontrolled hypertension Pre-existing severe comorbid cardio-respiratory disease History of type 1 diabetes or poorly controlled type 2 diabetes Abnormal liver biochemistry History of chronic gastrointestinal disease Specific genetic or hormonal cause of obesity Recent tobacco/nicotine product cessation (within 3 months prior)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roman Turro, MD
Organizational Affiliation
Gastroenterologist at Teknon Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Medico Teknon
City
Barcelona
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Procedure for Duodenal-Ileal Diversion for Patients With Weight Regain Following Sleeve Gastrectomy

We'll reach out to this number within 24 hrs